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This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS and NCATS expect to enhance the quality and increase the likelihood of success of clinical trials in these rare diseases.

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support research on bioethical issues to develop and evidence base that may inform future policy directions. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Areas of high priority research include, but are not limited to, the bioethical, legal, and societal implications of the following: New and emerging technology development and use; clinical and non-clinical data sharing; precision and personalized medicine; research privacy and security; learning healthcare systems; crowdsourcing; participant-driven research and consumer generated data; patient/participant representation in research oversight; special and vulnerable population research; individual or community health, treatment, and/or research disparities; issues related to the inclusion of Tribal and American Indian/Alaska Native populations; current and emerging regulatory environments; innovative study design, conduct, management, and oversight; international research; research on stigmatized conditions; historical analyses of bioethics issues; and novel approaches for enhancing bioethics infrastructure and training.

This purpose of this FOA is to identify risk factors for dementia progression in PDD. Applicants must have access to well-characterized populations of PDD patients that have been followed longitudinally that they can continue to follow with clinical assessments and biospecimen collection until autopsy. Research should propose to identify clinical, pathological and/or biospecimen factors that predict which patients will develop cognitive impairment and/or dementia.

This FOA invites applications that propose the comprehensive functional validation of newly identified therapeutic target candidates for Alzheimer's Disease-Related Dementias (ADRDs). This FOA seeks to promote critical target validation approaches to help de-risk subsequent translational research and accelerate the advancement of novel therapies for ADRD. Target(s) or molecular pathway(s) to be considered for validation must have been already identified using tissue expression or genetic data generated in human samples. In its initial phase, this FOA provided support for up to two years (UG3 stage) for the development of customized technologies, models, and protocols to modulate the expression or activity of target candidate(s) in cells or tissues and monitor their functional biological consequences in in vitro or in vivo disease models. Upon demonstration of technical feasibilities, a second phase (UH3 stage) will carefully and reproducibly measure and cross-validate the impact of the target modulation in different modalities across collaborating laboratories using the NIH rigor and reproducibility guidelines. Applicants responding to this FOA must address objectives for both the UG3 and UH3 phases and are expected to have a substantial collaborative effort between independents laboratories. This FOA is not specific for any one or group within the ADRD spectrum of disorders. Disorders covered in these applications are frontotemporal degeneration (FTD), Lewy body dementias (LBD) (including dementia with Lewy bodies (DLB)), Parkinson disease dementia (PDD), vascular contributions to cognitive impairment and dementia (VCID), mixed dementias including the associated diagnostic challenges of multiples etiology dementias (MED).

The purpose of this FOA is to provide support for institutional research training programs in areas relevant to the NINDS mission. These institutional research training programs should produce well-trained neuroscientists who leave the program with the research skills and scientific knowledge to make a significant contribution to neuroscience research. Programs should be designed to enhance the breadth and depth of training in NINDS mission areas by incorporating didactic, research and career development components in the context of a defined scientific theme. Programs may support basic, clinical and/or translational research. Critical components of programs supported by this FOA include mechanisms to ensure a thorough understanding of experimental design, strong statistics and analytical skills, and skills for communicating science, both orally and in writing, to a wide variety of audiences. Regardless of theme, programs should provide opportunities and activities that will foster the development of quantitative literacy and the application of quantitative approaches to the trainees' research. NINDS institutional training programs are intended to be 1-2 years in duration and support training of one or more of the following groups: dissertation stage predoctoral students in their 3rd and/or 4th year of graduate school, postdoctoral fellows and fellowship-stage clinicians. (NINDS does not support first or second year graduate students under this PAR).

The purpose of this FOA is to encourage mechanistic research to investigate the impact of sleep disturbances on pain. The mechanisms and processes underlying the contribution of sleep and sleep disturbances to pain perception and the development and maintenance of chronic pain may be very broad. This FOA encourages interdisciplinary research collaborations by experts from multiple fieldsneuroscientists, psychologists, endocrinologists, immunologists, geneticists, pharmacologists, chemists, physicists, behavioral scientists, clinicians, caregivers, and others in relevant fields of inquiry.

The purpose of this FOAs are to encourage mechanistic research to investigate the impact of sleep disturbances on chronic pain. The mechanisms and processes underlying the contribution of sleep disturbances to chronic pain development and maintenance may be very broad. This FOA encourages interdisciplinary collaborations by experts from multiple fieldsneuroscientists, psychologists,endocrinologists, immunologists, geneticists, pharmacologists, chemists, physicists, behavioral scientists, clinicians, caregivers, and others in relevant fields of inquiry.

This FOA invites investigation of biological and clinical measures of TBI-related progressive neurodegeneration and neurocognitive decline associated with increased risk for dementia and /or traumatic encephalopathy syndrome (TES) (clinicopathologic diagnostic counterpart to the neuropathological diagnosis of Chronic Traumatic Encephalopathy (CTE)). The overall goal is to advance knowledge of the underlying pathophysiology and clinical characterization of the chronic effects of TBI that distinguish static-chronic TBI cognitive impairment from those that lead to progressive neurodegeneration associated with TES and dementia. Investigations should be conducted in existing, well-characterized populations of patients with a history of TBI, enriched for increased risk of cognitive impairment or dementia, that have been and can continue to be followed longitudinally. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in this area.

This FOA invites applications for a multisite study to comprehensively characterize the neuropathological features associated with neurodegeneration and neurocognitive decline in persons with a history of traumatic brain injury (TBI). Investigations should elucidate the contribution of key individual (sex, age at time of injury, time since injury, etc) and injury characteristics (injury severity and frequency) to describe associations between neuropathological burden and antemortem clinicopathologic symptoms, and outline the prevalence of TBI-related parkinsonism, TBI-related Alzheimers, and CTE in the participating brain banks. To further advance research in the area, broad sharing of clinical and neuropathological data will be a critical feature of this FOA including the development of a digital resource for distribution and sharing of assessed neuropathological tissue.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating IC that the application is being submitted to and should not have a general STEM focus (see below and Table of IC-Specific Information and Points of Contact).